Alternatives in Toxicology

June 2012- Includes guidance regarding the use of alternatives to the rabbit pyrogen test (RPT) and the bacterial endotoxins test (BET) for detecting pyrogens in pharmaceuticals and other products. Examples of alternative assays cited include the recombinant horseshoe crab Factor C asssay and monocyte activation type pyrogen tests (MATs).

The objective of this workshop [was] to explore progress to date in implementing new, revised and alternative toxicological test methods across regulatory evaluation frameworks and decision-making programs in the U.S., identify barriers to progress and explore potential bridges to facilitate overcoming such barriers. These barriers may be technical, regulatory, economic or societal. Slides and speakers notes for all presentations are also available.

The program and presentation slides from a 2005 workshop that examined progress and barriers to date in implementing new, revised and alternative toxicological test methods across regulatory evaluation frameworks and decision-making programs.